1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Cuffless Non-invasive Blood Pressure Measuring Devices – Clinical Performance Testing and Evaluation Draft Guidance for Industry and Food and Drug Administration Staff January 2026

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2025-D-0851
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides the FDA’s recommendations on clinical performance testing and evaluation to support premarket submissions for cuffless non-invasive blood pressure measuring devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of cuffless non-invasive blood pressure measuring device submissions. 

Submit Comments

Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2025-D-0851.

Back to Top